[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.16]

[Page 542]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 900--MAMMOGRAPHY--Table of Contents
 
             Subpart B--Quality Standards and Certification
 
Sec. 900.16  Appeals of denials of certification.

    (a) The appeals procedures described in this section are available 
only to facilities that are denied certification by FDA after they have 
been accredited by an approved accreditation body. Appeals for 
facilities that have failed to become accredited are governed by the 
procedures set forth in Sec. 900.15.
    (b) FDA may deny the application if the agency has reason to believe 
that:
    (1) The facility will not be operated in accordance with standards 
established under Sec. 900.12;
    (2) The facility will not permit inspections or provide access to 
records or information in a timely fashion; or
    (3) The facility has been guilty of misrepresentation in obtaining 
the accreditation.
    (c)(1) If FDA denies an application for certification by a faciity 
that has received accreditation from an approved accreditation body, FDA 
shall provide the facility with a statement of the grounds on which the 
denial is based.
    (2) A facility that has been denied accreditation may request 
reconsideration and appeal of FDA's determination in accordance with the 
applicable provisions of Sec. 900.15(d).